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To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in adults
This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The person who is evaluated as overweight by the doctor will be invited to participate in this trial. The efficacy assessment items and questionnaires are collected at every visit of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| TCI378 Probiotics | Experimental | TCI378 Probiotics |
|
| TCI507 Probiotics | Experimental | TCI507 Probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | consume 1 capsule per day for 2 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change of body fat mass | The body fat mass (kg) was assessed by InBody770 | Weeks 0, 4 and 8 |
| The change of Triglyceride | Venous blood was sampled to measure concentrations of Triglyceride | Weeks 0, 4 and 8 |
| The change of Total cholestrol | Venous blood was sampled to measure concentrations of Total cholestrol | Weeks 0, 4 and 8 |
| The change of HDL-cholestrol | Venous blood was sampled to measure concentrations of HDL-cholestrol | Weeks 0, 4 and 8 |
| The change of LDL-cholestrol | Venous blood was sampled to measure concentrations of LDL-cholestrol | Weeks 0, 4 and 8 |
| The change of body mass index (BMI) | BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770. | Weeks 0, 4 and 8 |
| The change of body fat percentage | The body fat percentage (%) was assessed by InBody770. | Weeks 0, 4 and 8 |
| The change of visceral fat |
| Measure | Description | Time Frame |
|---|---|---|
| The change of fasting glycemia | Venous blood was sampled to measure concentrations of fasting glycemia | Weeks 0, 4 and 8 |
| The change of aspartate aminotransferase | Venous blood was sampled to measure concentrations of aspartate aminotransferase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LIOU JYH-MING | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan | 114 | Taiwan | ||
| National Taiwan University Hospital |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| TCI378 Probiotics |
| Dietary Supplement |
consume 1 capsule per day for 2 months |
|
|
| TCI507 Probiotics | Dietary Supplement | consume 1 capsule per day for 2 months |
|
|
The visceral fat (10 cm^2) was assessed by InBody770.
| Weeks 0, 4 and 8 |
| Weeks 0, 4 and 8 |
| The change of alanine aminotransferase | Venous blood was sampled to measure concentrations of alanine aminotransferase | Weeks 0, 4 and 8 |
| The change of albumin | Venous blood was sampled to measure concentrations of albumin | Weeks 0, 4 and 8 |
| The change of creatine | Venous blood was sampled to measure concentrations of creatine | Weeks 0, 4 and 8 |
| The change of uric acid | Venous blood was sampled to measure concentrations of uric acid | Weeks 0, 4 and 8 |
| The change of white blood cell | Venous blood was sampled to measure concentrations of white blood cell | Weeks 0, 4 and 8 |
| Taipei |
| Taiwan |